Acupuncture Versus Compound Diclofenac Sodium for Pain Relief in Non-Traumatic Acute Abdominal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-12-31

Brief Summary

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The investigators designed this clinical study to evaluate the efficacy and safety of semi-standardized acupuncture and moxibustion combined with compound diclofenac sodium injection in the emergency department (ED) compared with acupuncture or compound diclofenac sodium injection alone.

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Detailed Description

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This study is a prospective, parallel-controlled, open-label randomized controlled trial (RCT). The Numeric Rating Scale (NRS) was used to assess pain intensity. The primary outcome measure was the difference in pain response rates between the combined intervention group, the acupuncture-only group, and the diclofenac sodium combination group at 10 minutes post-treatment compared to baseline. Secondary outcomes included treatment response rates, NRS scores, pain recurrence rates, rescue medication rates, and adverse events at each observation time point across the three groups. Additionally, a placebo group was included to exploratorily assess the placebo effect of the intervention.

Conditions

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Acute Abdominal Pain Acupuncture Therapy Acupuncture Opioids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This study is classified as exploratory research. This designation is due to the specialized techniques required for acupuncture and sham acupuncture, as well as the significant differences in intervention methods between acupuncture and intramuscular injection of diclofenac sodium. Given these factors, a double-blind approach was not feasible in this study. To minimize open-label bias, the principal investigators, operators, outcome assessors, data collectors, and statistical analysts will act independently in all aspects of the trial.

Study Groups

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acupuncture group

acupuncture at Zusanli (ST36)

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type PROCEDURE

acupuncture at Zusanli (ST36); sample size: 44

compound diclofenac sodium

Intervention Type DRUG

intramuscular injection of compound diclofenac sodium injection; sample size: 44

acupuncture combined with compound diclofenac sodium

Intervention Type COMBINATION_PRODUCT

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44

placebo

Intervention Type COMBINATION_PRODUCT

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

compound diclofenac sodium group

intramuscular injection of compound diclofenac sodium injection

Group Type ACTIVE_COMPARATOR

acupuncture

Intervention Type PROCEDURE

acupuncture at Zusanli (ST36); sample size: 44

compound diclofenac sodium

Intervention Type DRUG

intramuscular injection of compound diclofenac sodium injection; sample size: 44

acupuncture combined with compound diclofenac sodium

Intervention Type COMBINATION_PRODUCT

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44

placebo

Intervention Type COMBINATION_PRODUCT

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

acupuncture combined with compound diclofenac sodium group

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

acupuncture at Zusanli (ST36); sample size: 44

compound diclofenac sodium

Intervention Type DRUG

intramuscular injection of compound diclofenac sodium injection; sample size: 44

acupuncture combined with compound diclofenac sodium

Intervention Type COMBINATION_PRODUCT

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44

placebo

Intervention Type COMBINATION_PRODUCT

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

placebo group

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline

Group Type PLACEBO_COMPARATOR

acupuncture

Intervention Type PROCEDURE

acupuncture at Zusanli (ST36); sample size: 44

compound diclofenac sodium

Intervention Type DRUG

intramuscular injection of compound diclofenac sodium injection; sample size: 44

acupuncture combined with compound diclofenac sodium

Intervention Type COMBINATION_PRODUCT

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44

placebo

Intervention Type COMBINATION_PRODUCT

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

Interventions

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acupuncture

acupuncture at Zusanli (ST36); sample size: 44

Intervention Type PROCEDURE

compound diclofenac sodium

intramuscular injection of compound diclofenac sodium injection; sample size: 44

Intervention Type DRUG

acupuncture combined with compound diclofenac sodium

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44

Intervention Type COMBINATION_PRODUCT

placebo

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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compound Diclofenac Sodium Injection

Eligibility Criteria

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Inclusion Criteria

1. The diagnostic criteria of NTAA were as follows: ① abdominal pain was the main symptom; ② The onset time was less than 1 week; ③ The cause of abdominal pain could be traced to intra-abdominal abdominal wall chest or systemic diseases;
2. Patients with NRS scores ≥4 (mild pain and above) were evaluated before inclusion; （3）16 years \< age \<75 years;

（4）Those who were considered not to need surgery within 2 hours after initial assessment by a specialist.

Exclusion Criteria

Participants meeting any of the following criteria were excluded from the study:

1. Acute abdomen caused by trauma;
2. Super sudden diseases (e.g. acute myocardial infarction rupture of abdominal aortic aneurysm pulmonary embolism aortic dissection pericardial tamponade);
3. Emergent conditions requiring surgical treatment within 3 hours (e.g. rupture of liver cancer ectopic pregnancy ischemic bowel disease severe acute cholangitis peritonitis with septic shock);
4. Extremely severe pain (NRS ≥ 8) with an undetermined diagnosis and requiring further assessment for a super sudden disease;
5. Inability to select acupuncture points due to skin injury or ulceration at Zusanli (ST36) on the lower limb;
6. Induration or infection at the hip injection site;
7. Patients with altered consciousness mental illness other severe chronic diseases or those who are unlikely to cooperate with acupuncture treatment;
8. Contraindications to Western medicine:

* Known allergies to diclofenac sodium or acetaminophen; ②History of asthma urticaria or allergic reactions induced by aspirin or other NSAIDs.

* Undergoing coronary artery bypass grafting (CABG) surgery. ④History of gastrointestinal bleeding or perforation following non-steroidal anti-inflammatory drugs (NSAIDs).

* Active gastrointestinal ulcers or bleeding or a history of recurrent ulcers or bleeding.

* Severe heart failure.
9. Use of any pain medication or acupuncture within the past 6 hours;
10. Previous participation in this study;
11. Pregnant or lactating individuals.

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No